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Famotidine 10 mg/10mg Tablet, 300 mg — NDC 72559-0038-23 package photo

Famotidine 10 mg/10mg Tablet, 300 mg

by Little Pharma, Inc. · 300 mg in 1 BOTTLE (72559-038-23)
NDC 72559-0038-23
🏷️ FDA NDC (as labeled) 72559-038-23 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0809-2026
Class I · Nov 6, 2025 — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. (Fresenius Kabi USA, LLC) · FDA recall D-0182-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72559-038-23
Product NDC 72559-038
11-digit billing NDC 72559003823
RxCUI 199047
UNII 5QZO15J2Z8
Application # ANDA215766
SPL Set ID 33dc93a5-ee03-2e68-e063-6294a90aeee1
Established class (EPC) Histamine-2 Receptor Antagonist
Mechanism of action Histamine H2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-15
Route ORAL
Dosage form TABLET
Substance FAMOTIDINE
Why two NDCs? The FDA registers this code as 72559-038-23 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72559-0038-23. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLittle Pharma, Inc.
Application holderANNORA PHARMA PRIVATE LTD
FDA applicationANDA215766 (ANDA)
Labeler code72559
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio23 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eat...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. Antacids (like Tums) neutralize acid that's already in your stomach — they work fast but don't last long. Famotidine is different: it actually blocks a signal in yo...
  • What exactly does famotidine do — and how is it different from antacids?
  • The over-the-counter tablets are meant to relieve heartburn when it happens, or to prevent it if you take them 10 to 60 minutes before a meal that usually causes trouble. You shoul...
  • Can I take the OTC version whenever I have heartburn, or is there a limit?
📖 Read our full Famotidine guide →
6
Nutrient depletion considerations

Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Famotidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintT;10
Size6 mm
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescarnuba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 10 mg 70000-0048-01 LEADER/ 30 tablets $0.092 — Availability likely —
good sense acid reducer 10 mg 00113-0141-65 L. 1 tablet $0.095 — Availability likely —
heartburn relief original strength 10 mg 00904-5529-52 Major 60 tablets $0.095 — Availability likely —
Famotidine 10 mg 46122-0735-65 Amerisource 30 tablets $0.095 — Availability likely —
Famotidine 10 mg 68001-0494-04 BluePoint 30 tablets $0.095 — Availability likely —
famotidine 10 mg 69230-0326-01 Camber 100 tablets $0.095 — Availability likely —
foster and thrive acid reducer 10 mg 70677-1102-01 Strategic 1 tablet $0.095 — Availability likely —
famotidine 10 mg 83324-0003-30 CHAIN 30 tablets $0.096 — Availability likely —
Acid Controller Original Strength 10 mg 00363-0141-65 Walgreen 1 tablet — — Discontinued —
Famotidine 10 mg 00363-4400-19 WALGREEN 90 tablets — — FDA listed —
Famotidine 10 mg 00363-9607-09 WALGREEN 30 tablets — — FDA listed —
acid relief 10 mg 11822-6141-00 Rite 1 tablet — — FDA listed —
Pepcid AC Original Strength 10 mg 16837-0872-10 Kenvue 10 tablets — — Discontinued —
Famotidine 10 mg 21130-0022-30 Albertsons 30 tablets — — FDA listed —
Famotidine 10 mg 21130-0039-09 Better 30 tablets — — FDA listed —
signature care acid controller 10 mg 21130-0249-65 Safeway 1 tablet — — Discontinued —
Acid Controller 10 mg 21130-0771-75 Safeway 90 tablets — — FDA listed —
Famotidine 10 mg 25000-0086-03 MARKSANS 30 tablets — — FDA listed —
TopCare Acid Reducer 10 mg 36800-0141-65 Topco 1 tablet — — FDA listed —
acid controller 10 mg 37808-0301-65 H 1 tablet — — FDA listed —
Famotidine 10 mg 37835-0161-50 Bi-Mart 50 tablets — — FDA listed —
equaline heartburn prevention 10 mg 41163-0313-65 United 1 tablet — — FDA listed —
Original strength heartburn prevention 10 mg 41226-0719-06 KROGER 30 tablets — — FDA listed —
heartburn relief 10 mg 41250-0493-65 Meijer 1 tablet — — FDA listed —
CareOne Acid Relief 10 mg 41520-0901-65 American 1 tablet — — Discontinued —
acid reducer original strength 10 mg 42507-0141-75 HyVee 90 tablets — — FDA listed —
Acid Reducer Original Strength 10 mg 43598-0824-18 Dr.Reddys 180 tablets — — FDA listed —
Famotidine 10 mg 43602-0511-03 Ascent 300 tablets — — FDA listed —
Equate Famotidine 10 mg 49035-0507-75 Wal-Mart 90 tablets — — FDA listed —
Famotidine 10 mg 49035-0589-19 Wal-Mart 90 tablets — — FDA listed —
Famotidine 10 mg 53943-0100-30 Discount 30 tablets — — FDA listed —
Famotidine 10 mg 54257-0180-07 Magno-Humphries, 90 tablets — — FDA listed —
Famotidine 10 mg 55111-0118-04 Dr. 120 tablets — — FDA listed —
Famotidine 10 mg 55319-0408-01 FAMILY 60 tablets — — FDA listed —
Famotidine 10 mg 55319-0426-60 Family 60 tablets — — FDA listed —
Famotidine 10 mg 55681-0343-03 TWIN 300 tablets — — FDA listed —
dg health heartburn prevention original strength 10 mg 55910-0141-60 Dolgencorp, 1 tablet — — FDA listed —
acid reducer 10 mg 56062-0141-65 Publix 1 tablet — — FDA listed —
Famotidine 10 mg 57896-0317-03 GERI-CARE 30 tablets — — FDA listed —
Famotidine 10 mg 58602-0705-09 Aurohealth 10 tablets — — FDA listed —
Famotidine 10 mg 58602-0828-19 Aurohealth 90 tablets — — FDA listed —
acid controller original strength 10 mg 59779-0141-39 CVS 30 tablets — — FDA listed —
heartburn relief original strength 10 mg 63187-0999-10 Proficient 10 tablets — — FDA listed —
Famotidine 10 mg 63868-0583-30 Chain 30 tablets — — FDA listed —
Famotidine 10 mg 63941-0009-09 Best 30 tablets — — FDA listed —
Famotidine 10 mg 68016-0800-30 Chain 30 tablets — — FDA listed —
Famotidine 10 mg 69256-0002-47 HARRIS 30 tablets — — FDA listed —
Famotidine 10 mg 69842-0063-19 CVS 90 tablets — — FDA listed —
Famotidine 10 mg 69842-0928-84 CVS 30 tablets — — FDA listed —
Famotidine 10 mg 71205-0637-30 Proficient 30 tablets — — FDA listed —
Famotidine 10 mg 71821-0012-08 VKT 288461 tablets — — FDA listed —
basic care acid reducer 10 mg 72288-0141-65 Amazon.com 1 tablet — — FDA listed —
Famotidine 10 mg/10mgthis 72559-0038-23 Little 300 mg — — FDA listed —
Famotidine 10 mg 72657-0112-20 GLENMARK 200 tablets — — FDA listed —
Welmate Famotidine 10mg 10 mg 73581-0108-09 YYBA 90 tablets — — FDA listed —
Heartburn Relief 10 mg 83059-0005-05 Shield 50 tablets — — FDA listed —
Heartburn Relief 10 mg 83059-0031-05 Shield 50 tablets — — FDA listed —
Famotidine 10 mg 83324-0139-30 Chain 30 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Famotidine — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Famotidine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$40.22M
Claims incl. refills
3.8M
Beneficiaries
2.6M
Spend / beneficiary
$15.35
Spend / claim
$10.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72559-0038-23 You're viewing this 300 mg in 1 BOTTLE (72559-038-23) 2025-05-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72559-038-23, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72559-0038-23, written without dashes as 72559003823. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72559-0038-23, the first segment (72559) is the labeler code FDA assigned to Little Pharma, Inc.; the middle segment (0038) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (23) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Little Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Little Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages

⏱️ Dosage and Administration 67 words ▾

Directions adults and children 12 years and over: to relieve symtoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

⚠️ Warnings 13 words ▾

Alergy Alert Do not us if allergic to Famotidine or other acid reducers

📦 Storage and Handling 20 words ▾

Other Information read the directions and warnings before use store at 20º to 25ºC (68º to 77ºF) protect from moisture

🧪 Active Ingredient 8 words ▾

Active Ingredient (in each tablet) Famotidine USP 10mg

🧪 Inactive Ingredients 17 words ▾

carnuba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide

🎯 Purpose 2 words ▾

Acid reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72559-0037-08 · Little 72559-0041-48 · Little →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.